As the Senior Director of Regulatory Affairs, you will architect and lead international regulatory strategy and execution to support Corcept’s international commercialization and expansion, starting with Europe. This role ensures all regional and local regulatory requirements are met in cooperation with Corcept functions responsible for clinical research, manufacturing, and commercialization. Staying attuned to the evolving regulatory environment, you will assess and communicate the impact of changes on business and product development programs. At times, you will directly represent Corcept with health authorities in Europe and elsewhere, as our expansion continues.

Responsibilities:

• Develop robust European regulatory plans, aligned with Corcept’s global strategy, that lead to commercialization in new countries 
• Provide regulatory guidance regarding European health authorities and interactions, including EMA 
• Contribute and independently execute the filing plans for Europe in line with corporate, regional, and local business objectives
• Maintain awareness of new and developing legislation, regulatory policy, and technical guidance relating to small molecule therapies across oncology, neurology, endocrinology, and metabolic therapeutic areas, and communicate their implications cross-functionally
• Review and provide strategic input/advice on EU CTR submissions and/or queries  
• Ensure high-quality regulatory submissions are made on time and achieve Corcept’s goals
• Build out a team that oversees regulatory-related launch and post-marketing activities in the EU
• Work closely with the Quality Assurance department on relevant regulatory procedures applicable to the European region

Preferred Skills, Qualifications, and Technical Proficiencies:

• Bachelor of Science in a scientific discipline, Pharm D (/Pharmacist) or PhD preferred
• 12+ years of experience with leading EU and non-EU regulatory submissions and interactions with EMA and national agencies
• Regulatory-related product launch and post-marketing activities experience 
• Experience with and knowledge of European regulatory regulations, directives, and guidelines
• Must be a strong team player, a fully engaged, hands-on professional capable of working collaboratively and independently, with excellent verbal and written communication skills

Preferred Education and Experience:

• Deep knowledge of European regulatory regulations, directives, and guidelines
• Passionate about strong and to-the-point written work product
• Excellent planning, organization, time, and stakeholder management skills, including the ability to support and prioritize multiple projects
• Strong interpersonal capabilities and ability to build and maintain networks globally
• Possesses a sense of urgency; identifies challenges and problems and takes the initiative to identify solutions

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The Quality Assurance Operations Manager is responsible for a variety of operational activities pertaining to assuring product quality and compliance with the manufacture, testing, control, validation, and release of pharmaceutical drug substance and drug product for commercial and clinical distribution. This role will also be responsible for the oversight of 3PLs and work closely with the QPs to distribute products in EU. This is a remote role.

Responsibilities:

• Act as Quality lead and support in various Chemistry, Manufacturing and Controls (CMC) projects
• Work cross-functionally with the CMC group to provide oversight and resolve quality investigations of issues that occur at contract manufacturing and testing organizations
• Perform review of executed batch records and test data and perform product disposition
• Review and approval of validation protocols and reports (e.g., process, method, etc.)
• Lead and support quality audit of contract service providers
• Develop, review, and revise Standard Operating Procedures (SOPs) to reflect current industry best practices and regulatory standards
• Generate and review Quality and Technical Agreements with Contract Service Providers (CSP)
• Perform quality trends analysis and reports, recommending continual improvements opportunities
• Support the management and growth of the Quality Assurance Operations team with the goal of attracting and developing talent, creating a rewarding professional environment, and ensuring that the team’s capabilities meet Corcept’s future needs
• Support the QP/RP to ensure timely disposition of batches
• Provide cross training development opportunities, mentor and coach junior QA team members

Preferred Skills, Qualifications and Technical Proficiencies:

• Strong QMS experience in the EU and knowledge of EU country specific requirements
• Strong technical knowledge of analytical chemistry and pharmaceutical manufacturing technologies and processes
• Strong experience with executed batch record review and in-depth knowledge of quality and regulatory requirements for the release of pharmaceutical products
• Ability to work independently and communicate effectively with project team members and management groups and suppliers
• Work well in a project team environment with solid problem analysis and decision-making ability
• Ability to lead or support internal and external compliance audits of suppliers, CTLs, and CMOs
• Ability to work independently in addition to clearly and concisely communicate both in writing and verbally
• Ability to identify compliance risk and recommend mitigations
• Ability to author, review, and approve SOPs and other controlled documentation for compliance with applicable regulations
• Strong statistical mindset and metric presentation
• Proficient computer skills are needed with experience using Microsoft Word, Excel, PowerPoint, and Visio
• Travel required

Preferred Education and Experience:

• Bachelor’s or master’s degree in science, engineering or related field
• At least 10 years in the bio/pharmaceutical industry
• At least 5-10 years in Quality Assurance
• Knowledge in application of 21CFR211, global cGMP regulations, and ICH guidelines regarding good manufacturing practices in the development, manufacturing, testing, delivery, and control of pharmaceutical products

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